@article{fdi:010081434,
  title = {{S}erious adverse reactions associated with ivermectin : a systematic pharmacovigilance study in sub-{S}aharan {A}frica and in the rest of the {W}orld},
  author = {{C}ampillo, {J}. {T}. and {B}oussinesq, {M}ichel and {B}ertout, {S}. and {F}aillie, {J}. {L}. and {C}hesnais, {C}{\'e}dric},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {I}vermectin is known to cause severe encephalopathies in subjects infected with loiasis, an endemic parasite in {S}ub-{S}aharan {A}frica ({SSA}). {I}n addition, case reports have described ivermectin-related serious adverse drug reactions (s{ADR}s) such as toxidermias, hepatic and renal disorders. {T}he aim of this study was to identify suspected s{ADR}s reported after ivermectin administration in {V}igi{B}ase, the {W}orld {H}ealth {O}rganization's global individual case safety reports database and analyze their frequency relative to the frequency of these events after other antinematodal drugs reported in {SSA} and other areas of the world ({ROW}). {M}ethods {A}ll antinematodal-related s{ADR}s were extracted from {V}igi{B}ase. {D}isproportionality analyses were conducted to investigate nervous, cutaneous, psychiatric, respiratory, renal, hepatic and cardiac suspected s{ADR}s reported after ivermectin and benzimidazole drug administration across the world, in {SSA} and {R}o{W}. {P}rincipal findings 2041 post-ivermectin or post-benzimidazole suspected s{ADR}s were identified including 667 after ivermectin exposure (208 in {SSA} and 459 in the {R}o{W}). {W}e found an increased reporting for toxidermias, encephalopathies, confusional disorders after ivermectin compared to benzimidazole drug administration. {E}ncephalopathies were not only reported from {SSA} but also from the {R}o{W} (adjusted reporting odds ratios [a{ROR}] 6.30, 95% confidence interval: 2.68-14.8), highlighting the fact these types of s{ADR} occur outside loiasis endemic regions. {C}onclusion {W}e described for the first time suspected s{ADR}s associated with ivermectin exposure according to geographical origin. {W}hile our results do not put in question ivermectin's excellent safety profile, they show that as for all drugs, appropriate pharmacovigilance for adverse reactions is indicated. {A}uthor summary {I}vermectin is a drug used worldwide for various indications: onchocerciasis, lymphatic filariasis, strongyloidiasis, human sarcoptic scabies, acarodermatitis and rosacea. {I}n the early 1990s, it was discovered that ivermectin could induce severe encephalopathies in some patients with high parasite loads of {L}oa loa, a filarial nematode. {T}his objective of this pharmacovigilance study is to summarize serious neurological and non-neurological post-ivermectin adverse drug reactions reported in the {W}orld {H}ealth {O}rganization database called {V}igi{B}ase. {T}his study shows that reported serious adverse drug reactions associated with ivermectin are fairly consistent with those mentioned in the official product information of ivermectin but also provides some new signals. {S}erious post-ivermectin encephalopathies can also occur outside of {L}oa loa endemic regions but the understanding of the mechanism by which it occurs requires further studies. {A} new signal concerning two serious toxidermias ({DRESS} syndrome and acute generalized exanthematous pustulosis) is also described. {A} lack of reporting of adverse drug reactions is noticeable in some {S}ub-{S}aharan {A}frican countries, and actions are needed to increase the reporting rates of these adverse effects in these countries.},
  keywords = {{AFRIQUE} {SUBSAHARIENNE} ; {MONDE}},
  booktitle = {},
  journal = {{PL}o{S} {N}eglected {T}ropical {D}iseases},
  volume = {15},
  numero = {4},
  pages = {e0009354 [18 ]},
  ISSN = {1935-2735},
  year = {2021},
  DOI = {10.1371/journal.pntd.0009354},
  URL = {https://www.documentation.ird.fr/hor/fdi:010081434},
}